Status:
TERMINATED
Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
Lead Sponsor:
The Cleveland Clinic
Conditions:
Respiration, Artificial
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol sedation - as determine...
Detailed Description
Patient will be selected from the ICU, based on the defined inclusion and exclusion criteria. Potential study subjects will be screened by the research fellow or the on-site study co-investigator. Eli...
Eligibility Criteria
Inclusion
- 18-80 years of age
- Written informed consent from relatives
- Clinically stable
- Mechanically ventilated \< 2days
- Require sedation and expected to be given propofol
Exclusion
- Recent injury or other pathologic condition of the esophagus
- Major bronchopleural fistula
- History of liver failure
- History of renal failure
- History of major neuromuscular disease
- Multiple trauma
- Upper motor nerve injury
- Hypersensitivity to propofol
- Recent gastrointestinal surgery
- Patients with a diagnosed or suspected condition that may give false results in BIS monitoring.
- Tracheostomized patients
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01173263
Start Date
July 1 2010
End Date
March 1 2011
Last Update
March 5 2014
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195